An International Study in Patients with Breast Cancer Spread to the Skin Using Electric Fields to Enhance the Efficacy of Chemotherapy

• Conditions: Breast cancer that has spread to the skin; MedDRA version: 14.0Level: PTClassification code 10055113Term: Breast cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-001998-10-SE
• Lead Sponsor: Department of Oncology University Hospital Uppsala

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07-14
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

•Male or female patients > 18 years of age
•Histological confirmed breast cancer
•Metastatic breast cancer (skin lesions only are considered as metastatic disease)
•Prior histological confirmation of at least one skin lesion
•Skin lesions must not have a depth greater than 3 cm (measured clinically if possible otherwise on the basis of CT/ultrasound examination
•Confluent skin metastases where individual lesions are hard to define in their entirety may not exceed a maximum area of 10 x 10 cm for each area of confluence. If there are several areas of confluence, the patient may be included in the study provided that all lesions can be treated within the time constraints of a single ECT session (20 minutes).
•Not more than ten skin lesions. Each area of confluence is considered as one lesion.
•A single skin lesion may not exceed 5 cm
•Patients may not have received more than one line of systemic treatment (chemotherapy or endocrine therapy) for metastatic disease following the discovery of skin metastases. Patients developing skin metastases for the first time during ongoing systemic therapy may receive one additional line of systemic treatment prior to inclusion.
•Patients in the early ECT arm may receive any other cancer treatments at the discretion of the treating physician starting no earlier than 2 weeks following ECT. This is to ensure that patients with metastatic disease in other locations will receive treatment that is considered suitable regardless of their participation in this trial. (If 2 weeks from ECT to the start of systemic treatment is judged to be too long by the treating physician, this patient should not be entered into the trial).
•Women of childbearing age must practice a suitable form of contraception.
•Patients must be willing to comply with the study protocol and give their written informed consent.
•A life expectancy of at least 6 months.
•Patients with a ECOG performance status < 3
•Signed Informed Consent

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

•Patients who have extensive and rapidly progressive visceral metastases where a delay in systemic therapy by eventual ECT is judged to not be in the patients` best interest
•Patients, who for medical reasons, cannot be given bleomycin
•Patients with brain metastases treated with surgery and/or radiotherapy who have progressive disease in the brain two months after treatment
•Prior cumulative dose of bleomycin exceeding 250,000 IU/m2
•Less than 14 days from previous cancer treatment (either local or systemic)
•If the patient has skin lesions that are situated in close proximity to a pacemaker such that an electrical field from ECT will overlap the pacemaker, the pacemaker must be moved to another location in order for the patient to be able to participate in the study
•Chronic renal failure (serum creatinine > 150?mol/L)
•Inadequate liver function defined as:
?ASAT or ALAT > 2.5 x ULN in the absence of liver metastases or > 5 in the presence of liver metastases
?or Bilirubin > 2 x ULN (except in the case of Gilberts Syndrome)
?or Albumin < 25 g/L
•Inadequate bone marrow reserve defined as:
?White blood cell count < 3 X 109/L
or Neutrophil count < 1.5 X109/L
or Platelet count < 100 X 109/L
•Any severe uncontrolled systemic disease.
•Unable or unwilling to comply with the study protocol

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified